Gust has been the Director of the Seattle Institute for Cardiac Research (SICR) since 2000. He has 36 years of experience as a clinician, researcher and clinical trialist and has designed, developed, executed and reported on four large international clinical trials as well as numerous single site trials. He has delivered three large NIH trials on time and within budget, including the SCD-HeFT, Home AED Trial and the SCD-HeFT 10-year trial as well as participated in other PI-directed NIH trials including CABANA and Bayesian Trials.  Further, he has designed and executed multiple industry-sponsored trials including multicenter international trials on new ICD technologies, including the active can ICD trials and the subcutaneous only ICD.  These either demonstrated the effectiveness of interventions that improved care (Bardy, NEJM 2005; Bardy NEJM 2010) or demonstrated the ineffectiveness of therapies that did not improve care but were being widely promoted or used.(Bardy, NEJM, 2008)  He has prodigious intellectual property with more than 200 US patients in the field of arrhythmia diagnosis and management and, as such, has extensive experience with identification and protection of new knowledge and transfer of it to industry so as to support research infrastructure. His clinical trial work, together with his innovations, have led to him receiving the 2014 Heart Rhythm Society award: Pioneer in Cardiac Pacing and Electrophysiology.

 

Graham is a scientist at SICR. He has a broad background in evaluation of interventions for patients who require acute resuscitation, with over 20 years of expertise and experience in both the development and implementation of clinical research. He serves as an attending physician in the emergency department of Harborview Medical Center and has extensive knowledge of contemporary clinical resuscitation practices. He served as medical director and co-principal investigator for the Resuscitation Outcomes Consortium (ROC) coordinating center at the University of Washington (UW) from July, 2004 to May, 2016. ROC was a multicenter network that was funded by the NIH to conduct a series of large simple trials to evaluate the effectiveness of interventions in patients with out-of-hospital cardiac arrest or life-threatening traumatic injury. He previously served as principal investigator of the economic and quality of life sub-study of the Public Access Defibrillation trial, national co-PI of a multicenter pilot randomized trial of intra-peritoneal hypothermia in patients with acute ST-elevation myocardial infarction, and co-PI of a large randomized trial of positron-emission tomography guided therapy in patients with poor ventricular function in the ambulatory setting. He served as lead investigator of the ROC Continuous Chest Compressions (CCC) trial, which was the largest trial of manual CPR by EMS providers reported to date. It was also the first trial that enrolled patients with out-of-hospital cardiac arrest in the field in a trial that demonstrated a significant difference between treatment groups after hospital admission. His work led to him receiving an Award of Merit from the American Heart Association. As well, he was recognized by Thompson-Reuters as one of the most influential scientists of 2015.

 

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Jo Ann is Director of Operations at SICR. She has 25 years of experience in regulatory compliance for medical trials and has been a research scientist at the University of Washington for 10 years.  She has served as a consultant to faculty and staff regarding internal and external research compliance policies and procedures on multiple types of research projects (i.e., observational studies, clinical trials, outcomes studies, drug and device trials, etc.) from various funding sources (i.e., federal, private, and industry sponsored).  She has developed study materials (protocols, recruitment and consent materials, human subjects applications, and data collection forms), research policies (i.e., Standard Operating Procedures), information management procedures and training programs for research personnel and physician investigators to ensure regulatory compliance.  Her knowledge of FDA regulations, ICH guidelines and Good Clinical Practices is extensive and is highlighted by her certification as a Clinical Research Professional from the Society of Clinical Research Associates (SoCRA).  In addition to her extensive regulatory knowledge, she has experience in assessing quality of life and neuropsychological function for medical patients.

 

Jill is Director of Clinical Studies at SICR. She has been at SICR since 2000 and has held key leadership positions in Clinical and Regulatory Affairs of large international NIH-sponsored studies of SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial), HAT (Home AED Trial), and SCD-HeFT 10 Year. These roles encompassed clinical and regulatory oversight of trial operations (grant applications, budgetary development and management and quarterly reporting, site monitoring, publications assistance, development of human subjects applications, consent and recruitment materials). She has 30 years of experience in Cardiac and Critical Care-related Research. Prior to her work at SICR, she served as a Critical Care Nurse at Harborview Medical Center’s Level 1 Trauma Center, Arrhythmia Research Nurse Practitioner at the University of Washington and Clinical Specialist at Medtronic, Inc in the Pacing and Implantable Cardioverter Defibrillator (ICD) Division. These roles encompassed intensive management and care of critically ill patients, pharmacologic and device management of atrial and ventricular arrhythmias and implementation of several multi-center clinical research studies. She has served as a Clinical Trials Consultant and Field Clinical Engineer for Medical Device Companies assisting with product development, Phase I- IV Clinical Trial execution and assistance.

 

Dipika is Director of Administration at SICR. She has substantial financial management experience including financial reporting, internal control, budget and forecast as well as audit. She managed development, implementation, and maintenance of sophisticated accounting systems and utilization of cost allocation methodologies. With more than 19 years of experience working with non-profit organizations, her expertise includes federal and state government contracts management, reporting, compliance, audit and project management. Her goal is to ensure accurate and timely financial and statistical reports for the organization, through keen oversight of budget, financial reporting and audit activities, as well as accounting system controls and standards. She has streamlined and consolidated operations, created and executed strategic plans and budgets for institutions, and consistently exceeded financial outcome through expense reduction and improved cash flow.

 

George is a Research Engineer at SICR. He has over 30 years of experience in the design and management of cardiology and emergency medicine related clinical trials, including the large international NIH-sponsored studies of SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial), HAT (Home AED Trial), SCD-HeFT 10 Year, and CABANA. For each of these trials, he was responsible for the design, implementation, and management of electronic communication and data collection & management systems. This included numerous primary study and core lab web sites, email systems, and other communication systems.

 

Jeanne's career has focused on the treatment and prevention of life threatening ventricular arrhythmias. She has participated in many clinical trials of implantable cardiac device therapy, including her roles as the PI of the NHLBI supported SCD-HeFT ICD Electrogram Core Lab, PI of the NHLBI supported Home Automatic External Defibrillator Trial (HAT) AED ECG Core Lab, PI for the NHLBI supported CABANA ECG/Rhythm Core Lab,  and PI for the SCD-HeFT 10-year Follow-up ICD Arrhythmia/EGM Core Lab. She has also completed a multicenter study examining complications related to pacemaker and ICD generator replacements (The REPLACE Registry) as the study PI. She has published numerous papers as first author or as mentor to the many fellows she has helped train in cardiology and cardiac electrophysiology. Through this work, she has gained extensive experience in the leadership of large multicenter and international clinical trials and sub-study analyses. Through her roles of directing the Core Labs of four NHLBI supported clinical trials, she has gained the knowledge and skills needed to manage their day-to-day workings and ensure their successful completion.